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Study of cabergoline compared to dienogest and ethinylestradiol for reducing endometriosis symptoms and lesion size in women with confirmed endometriosis

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on endometriosis, a condition where tissue similar to the uterus lining grows outside the uterus, causing pain and other symptoms. The research aims to test whether cabergoline tablets can help reduce the size of endometriosis growths and relieve pelvic pain compared to standard treatments.

The study will compare two different treatments. One group will receive cabergoline (0.5 mg taken twice per week), while the other group will receive standard treatment with either dienogest or combined birth control pills. The treatment period will last for 6 months.

During the study, doctors will monitor changes in the endometriosis growths using various imaging techniques such as ultrasound and magnetic resonance imaging. They will also track how well the treatment helps with pain and other symptoms. The study will also look at how the medications affect hormone levels in the body and overall quality of life for people with endometriosis.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial evaluation
A detailed assessment will be performed to confirm your endometriosis diagnosis using imaging methods (ultrasound or magnetic resonance imaging).
Your pain levels will be measured using a special scale called Visual Analogue Scale (VAS).
Basic health measurements will be taken, including height and weight to calculate your Body Mass Index (BMI).
Step 2
Treatment assignment
You will be assigned to receive either:
- Cabergoline tablets (0.5 mg twice per week)
- Standard treatment: Sibilla diario (dienogest/ethinylestradiol) tablets taken daily
Step 3
Treatment period
You will take the assigned medication as prescribed throughout the study period.
Regular check-ups will be scheduled to monitor your progress.
Your pain levels will be regularly assessed using the pain scale.
Blood tests will be performed to check hormone levels.
Step 4
Health monitoring
Your endometriosis lesions will be measured using imaging methods to track changes in size.
You will be asked to complete quality of life questionnaires.
Any side effects will be recorded, particularly focusing on nausea, vomiting, or dizziness.
Additional symptoms such as irregular bleeding will be monitored.
Step 5
Final evaluation
A final assessment of your endometriosis lesions will be performed using imaging methods.
Final pain level measurements will be taken.
A complete evaluation of your symptoms and overall health status will be conducted.
Final blood tests will be performed to assess hormone levels.

Who can join the trial?

10 criteria

Must be female aged between 18 and 40 years old and still having menstrual periods (premenopausal)
Must have a confirmed diagnosis of endometriosis through one of these tests:
- Ultrasound scan
- MRI (magnetic resonance imaging)
- Laparoscopy (a minor surgery where a camera is inserted through a small cut)
- Must have experienced pelvic pain for at least 1 month with a pain score of 3 or higher on a pain scale
- Must not have used the medication cabergoline in the past 3 months
- Must have a body mass index (BMI) between 18 and 35 (BMI is a measure of body weight in relation to height)
- Must not have any allergies to the study medications
- Must be willing to participate in the study and sign a consent form
- Must be able to communicate effectively with the study team and understand instructions

Who cannot join the trial?

14 criteria

History of hypersensitivity (severe allergic reactions) to cabergoline or similar medications
Pregnant women or those planning pregnancy during the study period
Currently breastfeeding mothers
History of heart valve disease (problems with heart valves)
Severe liver problems or abnormal liver function tests
Uncontrolled high blood pressure (hypertension)
Current use of other medications that might interact with cabergoline
History of fibrotic disorders (excessive tissue scarring) in any organ
Presence of other gynecological conditions that could interfere with the study results
Mental health conditions that could affect ability to follow study procedures
Any medical condition that the study doctor determines could make participation unsafe
Participation in another clinical trial within the past 30 days
Unable to provide informed consent
History of drug or alcohol abuse within the past year

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Verified sites

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Hospital Clinico San Carlos
Verified
Madrid, Spain

Trial locations

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Investigated drugs

Cabergoline is a medication that affects hormone levels in the body. In this trial, it's being tested to see if it can help reduce endometriosis symptoms and shrink endometriotic lesions. It belongs to a group of drugs called dopamine agonists, which are commonly used to treat various hormone-related conditions. Dienogest is a hormone medication commonly used as a standard treatment for endometriosis. It helps reduce pain and other symptoms associated with endometriosis by suppressing the growth of endometrial tissue. Combined hormonal contraceptives (also known as birth control pills) are standard medications used to treat endometriosis. They contain a combination of estrogen and progestin hormones that help control the menstrual cycle and reduce endometriosis symptoms.

What is already known about the treatment

Cabergoline
A dopamine receptor agonist medication administered orally in tablet form, typically taken twice weekly for endometriosis treatment. This drug works by binding to dopamine D2 receptors, which leads to a reduction in prolactin levels and may help decrease the size of endometriotic lesions while alleviating pelvic pain. Currently used in clinical trials for endometriosis management, cabergoline belongs to the ergot derivative class of medications and has shown promise in treating various hormone-related conditions, though its primary established use has been in treating hyperprolactinemia.
Dienogest
A synthetic progestogen medication taken orally once daily, specifically developed for endometriosis treatment as a standard therapeutic option. This drug works by creating a hormone environment that suppresses endometrial tissue growth and reduces inflammation associated with endometriosis lesions. Dienogest belongs to the progestin class of medications and has demonstrated significant effectiveness in managing endometriosis symptoms through its targeted action on endometrial tissue, with a favorable safety profile compared to other treatments.

Investigated diseases

Endometriosis - A chronic condition where tissue similar to the lining of the uterus grows outside the uterine cavity. This tissue can be found on the ovaries, fallopian tubes, and the tissue lining the pelvis. During each menstrual cycle, this misplaced tissue responds to hormonal changes, leading to inflammation and the formation of scar tissue. The condition typically develops several years after the onset of menstruation and can cause pain during menstruation, intercourse, and other pelvic activities. The displaced endometrial tissue can also affect fertility and cause irregular bleeding patterns.